Regulatory Affairs Specialist - Lifecycle & Labelling

Hikma Pharmaceuticals; Sintra; In loco; EUR 28.000 - 42.000; Tempo pieno

Vantaggi offerti da questo lavoro

Direct contract with Hikma

Life insurance

Health Insurance extended to student

Annual Performance Bonus

Real Growth Opportunities

Descrizione del lavoro

Hikma Pharmaceuticals is seeking an Officer, Regulatory Affairs (m/f) to join the Regulatory Affairs – Lifecycle team on-site in Portugal. This role supports day-to-day regulatory activities, labeling, and liaison with authorities to ensure compliant product launches.

The ideal candidate has 1–2 years in pharma regulatory work, strong English skills, and a proactive, collaborative mindset. Direct contract with Hikma includes life and health insurance and annual bonus opportunities.

Competenze

• Technical certification or relevant academic background.
• 1–2 years of regulatory experience in pharma is preferred.
• Good command of English, both written and spoken.
• Strong organizational and planning skills.
• Ability to work under pressure and meet deadlines.

Mansioni

• Provide administrative support for day-to-day regulatory activities.
• Coordinate labeling and packaging materials with Regulatory Authorities.
• Prepare, review and implement labelling.
• Liaise with partners, suppliers and internal clients.
• Open Change Controls and prepare variations of lower complexity.
• Prepare information for Annual Product Reviews.
• Create and revise SOPs and department documents.

Conoscenze

Regulatory knowledge

English proficiency

Communication skills

Organizational skills

Team collaboration

Proactive approach

Formazione

Technical certification or relevant academic background

Descrizione del lavoro

Hikma Pharmaceuticals is seeking an Officer, Regulatory Affairs (m/f) to join the Regulatory Affairs – Lifecycle team on-site in Portugal. This role supports day-to-day regulatory activities, labeling, and liaison with authorities to ensure compliant product launches.

The ideal candidate has 1–2 years in pharma regulatory work, strong English skills, and a proactive, collaborative mindset. Direct contract with Hikma includes life and health insurance and annual bonus opportunities.